Staff Regulatory Affairs Specialist

Stryker is currently seeking a Staff Regulatory Affairs Specialist to join our Ortho Tech – Mako and Enabling Technologies division to be based in Weston, Florida or remotely anywhere within the United States.

As the Staff Regulatory Affairs Specialist , you will join a regulatory affairs team supporting a portfolio of advanced orthopedic technologies across U.S. and global markets. You will work cross-functionally to ensure products remain compliant and available in dynamic regulatory environments. This role focuses on sustaining regulatory compliance, managing post-market activities, and supporting submission strategies for modified and existing products.

What you will do

• Develop and execute regulatory strategies for post-market products to maintain market access across global regions.

• Evaluate regulatory requirements and identify submission pathways for product changes, ensuring alignment with applicable regulations.

• Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals and updates.

• Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.

• Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.

• Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.

• Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.

• Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

What you need

Required

• Bachelor’s degree in engineering, science, or related field

• Minimum 4 years of experience in an FDA-regulated industry

• Minimum 2 years of experience in regulatory affairs

• Experience supporting regulatory submissions or compliance activities

• Knowledge of U.S. and international medical device regulations

Preferred

• Experience with Class II or Class III medical devices

• Experience authoring 510(k) submissions or equivalent regulatory filings

• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline

• Experience interacting with regulatory agencies or supporting regulatory meetings

Posted Date: 06/26/2026
This role will be posted for a minimum of 3 days.

United States of America Pay Ranges:

• Puerto Rico : $77,700 - $129,500 USD Annual
• USN : $95,700 - $159,500 USD Annual
• US5 : $100,500 - $167,500 USD Annual
• US10 : $105,300 - $175,500 USD Annual
• US15 : $110,100 - $183,400 USD Annual
• US20 : $114,800 - $191,400 USD Annual
• US30 : $124,400 - $207,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.